Registration Dossier
Registration Dossier
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EC number: 212-073-8 | CAS number: 759-94-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: maximisation test of Magnusson and Kligman
- Principles of method if other than guideline:
- see it in the full text
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- We had just data about this non-LLA method, and it showed positive skin sensitisation (H317). See it in the full text in the attachement.
Test material
- Reference substance name:
- EPTC
- EC Number:
- 212-073-8
- EC Name:
- EPTC
- Cas Number:
- 759-94-4
- Molecular formula:
- C9H19NOS
- IUPAC Name:
- N,N-dipropyl(ethylsulfanyl)formamide
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- corn oil
Challenge
- Route:
- intradermal
- Vehicle:
- corn oil
- No. of animals per dose:
- A group of thirty male guinea pigs was used for the
main study, twenty test and ten control.
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Challenge with the undiluted test sample elicited a slight irritant responsei n previously-inducegdu inea pigs. Challenge with a 30~ (w/v) preparation of the test sample in corn oil elicited a weak sensitisation response. Re-challenge with a 30~ or a 10~ (w/v) preparation of the test sample corn oil did not elicita sensitisation response in previously-induced guinea pigs. Therefore, EPTC was at most a weak skin sensitiseru nder the conditions of the test. In a positive control study, challenge with a 30~ (w/v) aqueous dilution a 40~ (w/v) formaldehyde solution elicited an extreme skin sensitisation response in previously-induced guinea pigs.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- EPTC is skin sensitiser: Skin sens 1 H 317
- Executive summary:
EPTC is skin sensitiser: Skin sens 1 H 317
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